Does the Prep support 21 CFR Part 11?

The Microlab Prep has a number of features that can support a laboratory’s compliance with the United States Food and Drug Administration’s 21 CFR Part 11.10 regulation. This article addresses each section of 21 CFR Part 11.10 and how the Prep can support compliance for each section.

What is 21 CFR Part 11?

In the United States, the Food and Drug Administration is responsible for protecting the health of humans and animals by regulating drugs, biological products, and medical devices. The 21 CFR Part 11 regulation is part of the FDA’s rules regarding proper documentation of materials in sensitive situations. Laboratories in the United States may need to comply with 21 CFR Part 11 by regulatory requirement, and the Prep can support that compliance.

(a) Validation of Systems

The Prep does not provide validation relevant to 21 CFR Part 11.10 (a) through the software, as the section pertains mainly to how validation is performed against computer systems in an organization.

(b) Accurate Generation of Records

When “Generate run reports” is enabled in the Software Configuration settings, the Prep generates a PDF report after executing a protocol. The report includes the following:

• The labware included in the run
• A photo of the deck and labware used
• Records of all pipetting activities
• Any errors that occurred
• Any pauses during execution

The reports can be viewed and exported to a USB drive from the Run History page in the Prep’s settings.

(c) Protection of Records

The Prep software allows the creation of database backups, which can be exported to a USB drive and restored at a later date. Restoring a database backup returns the instrument data to the time the exported database was created.

Backups are stored on the Prep for two weeks before they are removed as part of data maintenance.

(d) Limited System Access

When user management is enabled on initial setup or through the Users page in the Prep’s settings, users must log into the Prep software using their username and password to use the Prep. Configurable timeouts may be set to automatically log users out after a period of inactivity. Learn more about enabling or disabling user management here.

Each account has an assigned role which controls access to certain settings and features. For example, access to database backups and instrument settings are only accessible to users with the Laboratory Administrator role.

(e) Audit Trails

The Prep software tracks the following information for all protocols:

• Which user created the protocol
• Which user last modified the protocol
• Which user last ran the protocol
• The local date/time for each of these actions

Run reports generated after running a protocol include which user ran the protocol, the local date/time the protocol was last modified, and the starting and ending times for the run. The run report serves as a snapshot of the protocol as it was when it was run.

The ability to create, edit, and delete protocols is limited to users with the Assay Programmer or Laboratory Administrator roles.

(f) Operational System Checks

The Prep has a number of operational checks in place to ensure that regular functions are not performed out of order. These include but are not limited to:

• Certain functions (such as access to settings or creating/editing/deleting protocols) are restricted to users with a specific role when user management is enabled. To perform these functions, a user must first log in with an account that has the appropriate permissions.
• After a user makes any change to a protocol, they must verify the protocol, which checks for any errors that would prevent it from running.

(g) Authority Checks

When user management is enabled on initial setup or through the Users page in the Prep’s settings, all user accounts are assigned one of three roles:

• Laboratory Administrator: full access to all settings and protocols
• Assay Programmer: full access to protocols, able to perform maintenance and calibration, and view/export run reports
• Laboratory Operator: able to run/simulate protocols, maintenance, and calibration; able to view/export run reports

(h) Input Checks

The Prep accepts input via the attached touchscreen or a USB keyboard and mouse. Certain inputs are restricted to maintain data quality:

• Temperature, time, rate (RPM), counts, cycles, and percentage fields are restricted to whole-number precision
• Volume and length fields are limited to tenths (0.1) precision
• String (text) fields prohibit some characters from being used where applicable, including but not limited to: !, @, *, -, ^, ~, “, and #.
• The Prep can import worklists to drive pipetting activities, which are verified on import to meet the required CSV formatting.

(i) Education, Training, and Experience

Hamilton provides several forms of help content for the Prep:

• Page-by-page help file content built into the software
• Tutorial animations and step-by-step workflows for certain maintenance and calibration procedures
• An online knowledge base of help articles that is continually maintained, and supports a ticket-filing system to contact Hamilton support

(j) Policies for Using Signatures

The Prep does not support use of e-signatures, so any policies established to comply with 21 CFR Part 11.10 (j) cannot be directly supported on the Prep.

(k) Document Control

The Prep tracks when maintenance activities were last performed and when they must next be done. This information can be used by a lab to develop workflows for audit trails.